MAUDE Adverse Event Report: ICU MEDICAL INC TRIFUSE MICROCLAVE; SET, IV ADMINISTRATION

Model Number MC33098

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

Event Type  malfunction  

Event Description

Ivf (intra venous fluid) tubing trifuse disconnected from needless connector device on [date redacted] at 1310.Rn tightened trifuse connection to needless connector on [date redacted] at 0800.Trifuse was removed from patient, new lines with new ivf fluid were hung.

• Brand Name: TRIFUSE MICROCLAVE
• Type of Device: SET, IV ADMINISTRATION
• Manufacturer (Section D): ICU MEDICAL INC; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 10919178
• MDR Text Key: 218689978
• Report Number: 10919178
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC33098
• Device Catalogue Number: MC33098
• Device Lot Number: 490911
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 DA